It has become acceptable medical practice to provide a patient suffering post-operative pain with means for self-administering an analgesic pharmaceutical composition. This practice allows a patient more direct participation and control over the pain management program and has been shown to have a beneficial psychological effect and can promote the overall recovery and rehabilitation of the patient.
It is also well known that the intranasal administration of a pharmaceutical composition in the form of a liquid spray or aerosol can elicit a much prompter physiological response than other routes, such as oral administration.
As presently employed, the self-administration of pain killers, which are typically categorized as controlled substances by the DEA, requires the patient to be provided with a permanent intravenous catheter to which is attached a tube that is attached to a container suspended above the patient for gravity feed of the analgesic. The tube passes through a bulky electro-mechanical device that can include a metering pump and that includes a microprocessor that will override the patient's demand for infusion of the drug if it exceeds a predetermined prescribed frequency or volumetric dosage. In other words, the patient is prevented from overdosing by a pre-programmed valve and/or pump that stops the flow of the liquid analgesic to the patient. In addition to being expensive, the existing programmable devices and systems for the self-administration of analgesics such as the opioids and other controlled substances are bulky, require skilled personnel to set up at the patient's bedside, are expensive to maintain and occupy valuable space, not only in the patient's room but also in the health care facility's store rooms. These devices are also limited to the control of the administration of liquid pharmaceutical compositions via intravenous (and intra muscular) routes.
At least one opioid analgesic product has been approved by the FDA and is commercially available for nasal administration. The product is sold under the trademark STADOL®NS by Bristol Meyers Squibb of New York. The liquid pharmaceutical composition is contained in a screw cap bottle and is provided with a manually actuated pump for delivery of a spray into the nasal cavity. In addition to a priming procedure for the pump that is somewhat time-consuming and of potential difficulty for a post-operative patient suffering pain, the STADOL®NS system provides in excess of eight to twelve doses which could be self-administered in rapid succession by a patient that is not being supervised. This prior art device and system therefore requires the close supervision of hospital medical staff to assure that the patient does not overmedicate, and thereby self-administer a potentially lethal dose of the opioid. The container with the spray pump attached must also be removed from the patient's access in between doses. This procedure is time-consuming and burdensome for the medical personnel and is also potentially wasteful of the medication, since the system can only be used by one patient. A further drawback to this prior art system and its method of use is the known diversion and abuse that occurs as a result of the theft of the devices from the health care facility by workers.
It is therefore an object of this invention to provide a drug delivery device that will provide a plurality of predetermined doses of a pharmaceutical composition which can be used by a patient in need of treatment for the self-administration of one or more unit doses in accordance with a prescribed protocol that includes a time-delay between one or more prescribed unit doses.
It is a further object of the invention to provide a self-contained, compact and easily portable, programmable drug delivery device for the intranasal administration of a pharmaceutical composition that is safe, reliable and easy to use for self-administration by a patient in need of treatment.
Another object of the invention is to provide an intranasal drug delivery device which provides the administration of a precise volumetric unit dose of a controlled substance from a plurality of sealed containers in a system having access and control features that discourage diversion and abuse and that can deny use by unauthorized persons.